EUCTR2021-000563-69-SE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100 in Subjects with Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed written informed consent.
- •2.Males and females aged =18 years.
- •3.Diagnosis of diabetes mellitus type 1 or 2.
- •4.HbA1c = 86 mmol/mol (= 10%) at Screening.
- •5.Subjects with at least one first time or recurrent full thickness ulcer (at or below the ankle) which fulfils all of the following criteria at Screening and at the time of Baseline:
- •A non-interdigital wound
- •Accessible for administration of IMP, wound study assessments and procedures and possible to completely cover with the primary and secondary dressing
- •Persistence of the wound for at least 6 weeks at Baseline
- •Assessed by the investigator to be of non-venous etiology
- •Minimum full skin ulcer without undermining.
- •A wound area of 0.8-5.0. cm2 after sharp or mechanical debridement at Screening
- •Subjects with more than one eligible wound will have the largest, hence more clinically significant wound, selected at Screening as the index wound. Other wounds should at least be 3 cm apart and not impact the procedures or assessment of the index wound.
- •During the 2-weeks between start of Run-in Phase and Baseline the wound size must not decrease by more than 30% or increase by more than 25%, which correspond to wound areas of 0.6 – 6.3 cm2, or at Screening expected by the Investigator to have a high probability for wound size changes within this range during this period.
- •6. Toe pressure = 20 mm Hg. If toe pressure is not available ankle pressure =50 mm Hg, to allow inclusion of subjects with ischemic wounds, while excluding subjects with critical limb ischemia.
- •7.Expected to comply with the study procedures, including standard of care according to the protocol during the treatment phase and/or per local practise during assessment phase and long term follow up phase including off-loading.with off-loading and follow up schedule.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Infected index wound with clinical signs of inflammation (as per IWGDF/IDSA 2023 guidelines) at Screening or Baseline.
- •2. Confirmed osteomyelitis (as per IWGDF/IDSA 2023 guidelines) at Screening or Baseline.
- •3. The index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressing.
- •4.Wound duration longer than 2 years.
- •5.Active Charcot deformity of the study foot (i.e., foot is erythematous, warm, edematous, and is actively re-modelling).
- •6.Estimated eGFR <30 mL/min/1.73m2, by MDRD calculation
- •7.Hemoglobin concentration <100 g/L at Baseline.
- •8.Planned or ongoing treatment with corticosteroids to an equivalent dose of prednisolone >10 mg per day or other immunosuppressive therapy, or such treatment within 4 weeks prior to Baseline.
- •9.Has any major surgery or hospitalization planned up to Week 26.
- •10.Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dose change is allowed.
- •11.Revascularization procedure in the index wound leg planned or undertaken within 8 weeks before Screening, or under investigation
- •12. Participation in other clinical studies or having received any investigational treatment within 1 month or at the earliest five time the half-life prior to Screening.
- •13.Has any disease conditions, including ulcerative dermatological disorders and vasculitis, or comorbidities which is expected to prevent the subject from participating in the study or confounding the evaluation of the safety profile and effect on wound healing of ILP100.
- •14.Pregnant or lactating woman.
- •15.Male subjects not willing to use condom to prevent pregnancy and drug exposure of a fertile female partner and refrain from donating sperm from the date of the first dose until negative results from Week 16 in wound swabs, skin swabs, blood and feces analyses concerning findings of L. reuteri R2LC containing the pSIP_CXCL12 plasmid.
- •16.Female subjects of childbearing potential unless they use a contraceptive method with a failure rate of < 1% to prevent pregnancy from the start of the Run-in Phase until negative results from Week 16 in wound swabs, skin swabs, blood and feces analyses concerning findings of L. reuteri R2LC containing the pSIP_CXCL12 plasmid. Effective contraceptive methods include:
- •oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable or implanted hormonal contraceptives
- •intrauterine device
- •intrauterine system (for example progestin-releasing coil)
- •vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- •bilateral tubal occlusion or hysterectomy.
- •Female subjects are considered of non-childbearing potential if they are pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months’ amenorrhea.
- •17.Inability to provide informed consent, for example due to disorders affecting cognition or communication.
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